Appeal No. 2004-2202 Page 5
Application No. 10/016,324
In this case, although Marshall’s disclosure is not without ambiguity, we agree
with Appellants that the reference has not been shown to anticipate the claims.
Marshall teaches cationic amphiphiles comprising a lipophilic group (preferably a
steroid, see column 22, lines 12-15) attached to a cationic group. Marshall teaches that
“co-lipids that are useful . . . for mixing with one or more cationic amphiphiles include
dioleoylphosphatidylethanolamine (‘DOPE’)”. Column 32, lines 28-30. Marshall also
teaches that polyethylene glycol 5000-dimyristoylphosphatidyl ethanolamine (PEG(5000)-
DMPE) “is believed to stabilize the therapeutric [sic] compositions by preventing further
aggrregation [sic] of formed amphiphile/DNA complexes.” Column 53, lines 46-49.
Thus, Marshall appears to teach a composition comprising vesicle-forming lipids (e.g.,
DOPE), hydrophilic polymer chains (e.g., PEG(5000)), and a therapeutic agent (e.g.,
DNA).
However, we agree with Appellants that Marshall does not anticipate because it
does not teach liposomes having the therapeutic agent entrapped within them. Marshall
teaches that the
[p]harmaceutical compositions of the invention facilitate entry of
biologically active molecules into tissues and organs. . . . The amphiphilic
nature of the compounds of the invention enables them to associate with
the lipids of cell membranes, other cell surface molecules, and tissue
surfaces, and to fuse or to attach thereto. One type of structure that can
be formed by amphiphiles is the liposome, a vesicle formed into a more or
less spherical bilayer. . . . However, unlike the case for many classes of
amphiphiles or other lipid-like molecules that have been proposed for use
in therapeutic compositions, the cationic amphiphiles of the invention need
not form highly organized vesicles in order to be effective, and in fact can
assume (with the biologically active molecules to which they bind) a wide
variety of loosely organized structures.
Column 33, lines 25-47.
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